SUPERVISOR: Cornelia KASPER

PROJECT ASSIGNED TO: Sabrina NEBEL

Over the last decades, in addition to traditionally inert biomaterials like titanium, cobalt-chromium alloys or ceramics, scaffolds that actively promote tissue repair have emerged. Tissue Engineering aims to generate ‘living tissue replacements’ in vitro by the combination of cells with biomaterials providing physiological culture conditions, biochemical signals, and mechanical stimulation. Further development of so called advanced medicinal products, including cell or gene therapy are bridging the gap between medicinal products and pharmaceuticals. With increasing complexity of the mode of action, improved testing systems were called for. Thus, so called potency assays have emerged, defined as following:

“The measure of the biological activity using a suitably quantitative biological assay (also called potency assay or bioassay), based on the attribute of the product which is linked to the relevant biological properties.” – Guideline on Potency Testing, EMA 2017

Current cell-based potency assays mainly rely on static 2D culture of transformed cell lines, which makes them well-defined and reproducible but far off from physiological conditions. Especially in early stages of drug development and characterization testing system should emulate the actual circumstances.

Considering all these aspects, new bioprocess strategies to provide a more physiological potency assay platform considering the biomaterial, the physiological 3D environment, and the implemented cells, have to be developed.

The idea of this project is to establish well defined cultivation solutions that cover isolation of primary cells, their expansion and translation to a potency assay platform. Traditional cell culture and even standardized tests do not take physiological conditions like oxygen levels 3D structure and mechanical forces into account. In this project the influence of hypoxic conditions and especially cell-material interactions in dynamic 3D culture systems will be investigated.